Replies to post #139759 on Avid Bioservices Inc (CDMO)

[cheynew]

Thanks for your comments, Thurly. You have always been a voice of reason.

[md1225]

Great to see you post Thurly!

May I say I respectfully disagree... Big pharma J&J did not say to PCYC three years ago on their phase I/II data for their BTK inhibitor we'd like to see more data, we'd like to see a true phase II trial or a phase III...
They partnered on data based on 76 patients....
They Partnered on safety and the "Blockbuster" potential..
Big pharma has no problem dropping money on a lottery ticket..
And Bavi is a lottery ticket that works...

Great to see you post :)

[Protector]

Thurly, things are often not turning the way ones originally thinks.

You yourself had predicted with near certainty that the 2nd ln NSCLC clinical trial, would never pass the FDA and you even had put up a complete argumentation for it. Yet today we know it passed brilliantly and that Garnick even stated there wasn't even the beginning of a question about the salvaged data by the FDA. So you see.

Shan's possible slip of the tongue "confirmational trial" is probably the trigger that lead to yesterdays announcement of the "interim look in". PPHM is clearly wanting to play this down for some reason, first by Garnick saying they would like an early something (say AA, interim look, etc without being very explicit about it), then Shan's clearly non-intended confirmational trial statement and now suddenly the interim look in, something they could have told us a good while back because they clearly KNEW it already at that time!

So they are reluctant to communicate but they do, as vague as possible, communicate. So I say there is a legal reason or they want to trumpet the surprise in full just before the Annual Meeting in a couple of weeks.

I see your stay in the UK has brought British humor to the table :)

At this point, the data is, functionally, a black hole—there are huge biostatistical uncertainties.

BP's know it works! BP's know the FDA find nothing 'irregular' in the data as you claim. BP's have seen the Bavi safety database for ALL trials combined, near 500 patients now. BP's have seen Bavi also perform in other conditions (eg: Breast), BP are VERY aware what it means 'no CURRENT plans' for Pancreatic (they understand the sub ECOG results too).

So BP's are in no case worried about about a black hole because in SEPT 2012 Bavi's MOA wasn't as good understood as it is now. Yet, it apparently was sufficiently good at the time to keep Management out of bed to do their day jobs at night and for at least 15 disclosed partnership meetings. The price increased and that is why we don't hear about the partnerships and PPHM got stronger at that table. The hold both the stick and the carrot and they own the donkey! (I know, that's an open door :)

I don't agree with your loan analysis. We wouldn't have needed the ATM if Fargo hadn't happened. IMO, we would have partnered. So terribly sad.

Don't mix up both. We returned the loan and used the ATM to get the cash back in. That is INDEED Fargo's (CSM our 3rd party CRO) fault in this double blinded clinical trial in which PPHM couldn't be involved until unblinding.

Yes, we'dd probably would have partnered. Thank heaven we didn't because the payments would have been a fraction of what they'll be now with the PIII in our pocket and knowing about the Upstream qualities of Bavi.

And everyone will tell you that if you need a NEXT loan, after getting 30Milj$ (2x15) and NO POSSIBILITY to raise in competition with the bank by getting it from another bank or the ATM, that you may quietly and well behaved accept the bankers conditions if you want more. And with those bankers having a pile of potential stock there comes a point where NOT GIVING you more cash FORCES you to accept a bid from a BP (that may even be a BIG customers of theirs too and could become it!). And that bid may not exactly be what PPHM, or for that matter any of us, might think the Bavi potential is worth! So let's agree that we disagree on the loan.

[until2000]

I was surprised to hear that they are considering using a hundred different sites.

this means recruiting only 6 candidates per site, it seems to me that this will make recruitment that much easier.

My main concern is monitoring the dosages. And I hope and feel somewhat sure that Dr. king and Dr. Shan will see to it that there is someone in place to make sure the doses are not switched this time.

After yesterdays discussion, I feel more confident that they can enroll in a timely manner.

It is, however, becoming clearer to me that they would prefer to go it alone.